There may be a significant time between when a participant enrols in a project and when any outcomes from the research are available. This may be due to the project's duration, or the time taken to recruit the number of participants needed for data analysis. In these cases, it shows respect to the participant to provide updates on the progress of the project. Such updates, including the number of participants or active sites, are considered meaningful by many participants.
Considerations
- Researchers could seek approval for planned study updates via a template outlining the content that will be included, the channels that may be used (such as via a written document, a video or audio version of the same content, or a conversation between the study staff and the participant), and the triggers for sending this information.
- Researchers could usefully discuss with ethics review bodies whether every instance of the study update needs prospective review or if another form of oversight (such as a Submission for Acknowledgement, or notification in the Annual Report) would be appropriate for lower risk communications.
- Updates that contain only information that is already publicly available and non-promotional in intent (e.g., on the ANZCTR, or peer reviewed publications) or that are focused on increasing familiarity with the site, or site staff, may not require ethics approval for each instance.
- Studies may also be abandoned for a number of reasons, which cannot be planned for in advance and any updates of this nature would need ethics approval.
Participant experience
- Updates about study progress are particularly important for projects where there is a long involvement period for the participant, or there is a long time between when the participant’s involvement finishes and the study results are released.
- If a study closes early, participants should be told why.
- A single sheet where I could see at a glance where the study is at, with pictorials and things like that, would be far more beneficial than having a lot of information overload.
- I don't think you need to do it just for the sake of it, but there might be certain milestones where it is important.
- On my first trial people were dying which was distressing. If it was that kind of situation, you’d need to ask how much information people want at the beginning.
- Trials get stopped for many reasons, as we know, and even that information is important for participants.
- I’m 13 years into a clinical trial, and I’ve never received any updates . The only way I know anything is because I have a professional role, and I see it at scientific meetings.
Suggestions
- Milestones for sending updates should be pre-set in discussion with consumers and site staff to develop a schedule that is feasible to implement and not overwhelming for participants.
- Updates could be about progress with recruitment or changes in staffing or sites if updates about interim results are not available.
- Updates do not need to be long, and should be formatted like a press release, with the key points in simple language up front.
- Possible formats include phone calls, texts/emails, newsletters, podcasts, presentations or workshops in the community
